Phase 2b study of SPN-820 failed to meet primary endpoint for depression. No significant difference between SPN-820 and placebo was found. Safety profile for SPN-820 remains consistent with past trials. Onapgo injection approved, set for market in Q2 2025. SUPN stock down 14.10% following trial results.
Piper Sandler downgraded SUPN to Neutral, citing unmet Qelbree prescription growth. Qelbree sales grew 92% YoY but long-term growth assumptions are re-evaluated. Peak sales projections for Qelbree adjusted from $500M to $400M. FDA granted resubmission of SPN-830’s NDA, with PDUFA date set for Feb 2025. SUPN stock fell 7.17%, reflecting market reactions to the downgrade.